PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K112302
Device Name PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES
Applicant
COOPER VISION, INC.
6150 stoneridge mall road
pleasanton, 
CA 
94588

Applicant Contact lisa hahn
Correspondent
COOPER VISION, INC.
6150 stoneridge mall road
pleasanton, 
CA 
94588

Correspodent Contact lisa hahn
Regulation Number 886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received 08/11/2011
Decision Date 12/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No